中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
如果您的注册档案首次未通过技术完整性检查 (TCC),您将有 4 个月的期限,在此期间您有一次机会修改不完整性。如果您未能在规定的期限内提交完整的档案,您的提交将被拒绝。新注册被拒绝意味着您的物质不会获得注册号,并且为此次注册支付的任何费用将不予退还或以其他方式记入。因此,只有在您完成注册并获得 ECHA 颁发的注册号后,您才可以开始制造/进口该物质,或者生产或进口物品。如果您希望继续注册,则需要重新进行初始提交。这将需要重新进行完整性检查并支付注册费。注册更新被拒绝意味着您保留现有的注册号,但更新中包含的任何新信息都不会收录到 ECHA 的数据库中。为此次注册更新支付的任何费用将不予退还或以其他方式记入。如果更新涵盖了吨位范围的变化,则在 ECHA 确认您的注册更新完成之前,您不得制造/进口该物质,也不得生产或进口含有增加的吨位范围的物品。如果提交的注册档案更新包括该物质的纳米形式,那么拒绝意味着,即使您保留该物质非纳米形式的现有注册号,该注册也不涵盖该物质纳米形式的制造或进口。在 2020 年 1 月 1 日之后制造/进口该物质的纳米形式而没有涵盖这些纳米形式的注册的注册人违反了 REACH 法规,这可能会触发执法措施。因此,如果您包含纳米形式的注册更新被拒绝,您需要尽快提交新的注册更新,以履行您对纳米形式的义务。
Answer (EN)
If your registration dossier fails the technical completeness check (TCC) for the first time, you are given a deadline of 4 months during which you have one chance to amend the incompleteness. If you fail to submit the complete dossier by this given deadline, your submission will be rejected.
Rejection of a new registration means that the registration number is not assigned to your substance and any fees paid for this registration will not be refunded or otherwise credited. Consequently, you may only start to manufacture/import the substance or to produce or import an article once you have a complete registration and ECHA has issued you a registration number. If you wish to proceed with your registration you need to make a new initial submission. It will be subject to a new completeness check and registration fee.
Rejection of a registration update means that you maintain your existing registration number but any new information included in that update will not be included in the ECHA’s database. Any fees paid for this registration update will not be refunded or otherwise credited. If the update covered a change of tonnage band, you may not manufacture/import the substance or produce or import an article containing it at the increased tonnage band until ECHA has confirmed that your registration update is complete.
If the update of the registration dossier was submitted to include nanoforms of the substance then the rejection means that, even though you maintain your existing registration number for the non-nanoforms of the substance, the registration does not cover the manufacture or import of the nanoforms of the substance. Registrants that manufacture/import nanoforms of the substance after 1 January 2020 without a registration that covers these nanoforms are in breach of the REACH regulation which may trigger enforcement measures. Therefore, if your registration update to include nanoforms was rejected, you need to, at earliest possible, submit a new registration update in order to fulfil your obligations for nanoforms.